Infant microbiome formula improves eczema severity and QoL in preschool children

A novel infant microbiome formula (SIM03) containing unique Bifidobacterium bifidum and Bifidobacterium breve strains improves eczema severity and quality of life (QoL) in preschool children, shows a study by the Chinese University of Hong Kong (CUHK).

“Our territory-wide survey [published in 2009] found that close to one-third of preschool children in Hong Kong have ever had eczema,” wrote the researchers. [Pediatr Allergy Immunol 2009;20:339-346] “Microbiome alteration has been shown to contribute to eczema predisposition and its worsening, and children with eczema are known to have reduced gut microbial diversity vs healthy children. In addition, the abundance of bifidobacteria in the gut was found to be inversely correlated with eczema severity in children.” [Front Immunol 2020;11:1907; J Allergy Clin Immunol 2003;111:587-591]

The present open-label pilot study aimed to evaluate the effectiveness and safety of SIM03 on clinical outcomes including eczema severity, QoL and gut microbiome composition in young Chinese children with eczema. The SIM03 formula contains unique B. bifidum and B. breve strains, which were identified as lacking in children with eczema through big data analysis of large metagenomic datasets. The formula is produced using microencapsulation technology to protect these bacteria and enhance their gut delivery.

The study involved 20 children aged 1–5 years (mean age, 3.0 years; male, 40 percent), of whom six had mild, four had moderate and 10 had severe eczema, according to SCORing Atopic Dermatitis (SCORAD) scores. Subjects consumed one sachet of SIM03 (with milk or 10–20 mL lukewarm water) twice daily for 3 months. [Sci Rep 2024;14:3168]

Total median SCORAD score significantly decreased from 25.6 at baseline to 16.2 at 2 months (p=0.008) and 14.6 at 3 months (p<0.001). QoL also significantly improved in children aged 1–3 years (as per Infants’ Dermatitis Quality of Life Index [IDQOL]) and children aged 4–5 years (as per Children’s Dermatology Life Quality Index [CDLQI]) at months 1, 2 and 3 (p range, 0.002–0.014).

“SIM03 was well tolerated and treatment adherence was 99.5 percent,” reported the researchers.

Metagenomic sequencing of subjects’ faecal samples showed an increase in relative abundance of B. breve (p=0.0014) and B. bifidum (p=0.080) following 1 month of SIM03 treatment. There was also a marginal increase in richness of overall microbial pathways at 1 month (p=0.089).

More than half of subjects whose B. bifidum abundance increased following treatment experienced less sleep loss, while subjects with unchanged abundance of B. bifidum did not report improved sleep. There was also a trend towards greater improvement in pruritus score among subjects with increased B. bifidum abundance vs those without.

While none of the SCORAD scores differed significantly between subjects with or without increase in B. bifidum after 3 months of SIM03 treatment, relative abundance of B. breve inversely correlated with the extent (p=0.023) and intensity (p=0.019) components of SCORAD in subjects with increased B. breve at 3 months.

“Eczema patients need to select targeted probiotics that can benefit their condition. Our team successfully identified a unique group of bifidobacteria that are deficient in children with eczema, developed a unique microbiome formula, and showed that interventions that restore beneficial bacteria in the gut can improve eczema,” said Professor Francis Chan of the Centre for Gut Microbiota Research at CUHK. “This study provides important data to design a large-scale clinical trial for elucidating the efficacy and safety of this novel treatment option for children with eczema.”